UNC Lineberger’s Clinical Immunotherapy Program is conducting chimeric antigen receptor T-cell (CAR-T) clinical trials that are currently open for patient accrual. These experimental treatments involve re-engineering cells from the patient’s immune system to recognize and direct the attack against the patient’s cancer.
UNC Lineberger’s Clinical Immunotherapy Program has a robust clinical trials program that currently has six trials open for patient accrual.
Program faculty are also in the process of developing several other study protocols, including trials that will target glioblastoma multiforme and neuroblastoma are expected to open by mid 2019.
Relapsed/Refractory Multiple Myeloma
LCCC1603-ATL: Phase I Study of the Administration of Autologous CAR-T cells Targeting the CD138 Antigen in Patients with Relapsed/Refractory Multiple Myeloma. The primary purpose of this study is to determine whether the administration of CAR T cells targeting CD138 is safe and tolerable and to evaluate an optimal dose of cells to give as treatment. Principal Investigator: Sascha Tuchman, MD
CD30+ Relapsed/Refractory Hodgkin Lymphoma and CD30-expressing T cell lymphoma
LCCC1606-ATL: Phase I Study of the Administration of Autologous CAR-T cells Targeting the CD30 Antigen and Expressing CCR4 in Patients with CD30+ Relapsed/Refractory Hodgkin Lymphoma and CD30-expressing T cell lymphoma. The trial evaluates the safety and tolerability of CAR T cells targeting CD30 in patients with CD30-expressing Hodgkin or T cell Lymphoma. The trial also evaluates whether the inclusion of CCR4 into the CAR treatment will enhance the presence of CAR T cells at tumor sites. Principal Investigator: Natalie Grover MD
Relapsed/Refractory Acute Lymphoblastic Leukemia
LCCC1541-ATL Phase I Study of the Administration of Autologous CAR-T Cells Targeting the CD19 Antigen and Containing the Inducible Caspase9 Safety Switch in Patients with Relapsed/Refractory Acute Lymphoblastic Leukemia. The primary purpose of this study is to determine whether receiving iC9-CAR19 cells is safe and tolerable and later to determine an optimal dose of AP1903 to be given to subjects to alleviate severe cytokine release syndrome or neurological complications from CAR T cell therapy. Principal Investigator: Matthew Foster, MD
CD30+ Lymphoma in patients undergoing autologous stem cell transplant
LCCC1524-ATL Phase I Study of the Administration of T Lymphocytes Expressing the CD30 Chimeric Antigen Receptor (CAR) for Prevention of Relapse of CD30+ Lymphomas after High Dose Therapy and Autologous Stem Transplantation (ATLAS). This study is available to patients with high-risk CD30+ lymphoma who are undergoing an autologous stem cell transplant as therapy. Study participants will receive high-dose chemotherapy and autologous stem cell transplant followed by infusion of autologous CAR T-cells directed against CD30. This study is designed to evaluate the safety of this therapy. Secondary endpoints evaluate the clinical activity of this treatment. Principal Investigator: Thomas C. Shea, MD
Relapsed/Refractory CD30+ Hodgkin’s Lymphoma and CD30+ Non-Hodgkin’s Lymphoma
LCCC1532-ATL Phase Ib/II Study of the Administration of T lymphocytes Expressing the CD30 Chimeric Antigen Receptor (CAR) for Relapsed/Refractory CD30+ Hodgkin’s Lymphoma and CD30+ Non-Hodgkin’s Lymphoma. Patients must be 18 years and older. This trial studies the efficacy of CAR T cells targeting CD30 in treating patients with relapsed/refractory CD30+ Hodgkin lymphoma or non-Hodgkin lymphoma that expresses CD30. Patients who have failed treatment with autologous or allogeneic stem cell transplantation are eligible for this therapy. Principal Investigator: Anne Beaven, MD
Relapsed/Refractory B cell Non-Hodgkin Lymphoma
LCCC 1813-ATL Administration of Autologous CAR-T Cells Targeting the CD19 Antigen and Containing the Inducible Capsase 9 Safety Switch in Patients with Relapsed/refractory B cell Non-Hodgkin Lymphoma. Principal Investigator: Grover Natalie, MD
If you wish to refer a patient or have questions about any of the clinical trials, please contact Catherine Cheng, 919-445-4208, for more information.